Arcus Biosciences disclosed updated efficacy data for its HIF‑2α inhibitor casdatifan from the Phase 1/1b ARC‑20 study on February 23, 2026. The analysis, based on a data cut‑off of January 30, 2026, focuses on the 100 mg once‑daily dose that is being used in the ongoing Phase 3 trial.
The 100 mg cohort achieved a median progression‑free survival of 15.1 months and a confirmed overall response rate of 45 %. Landmark rates were 61 % at 12 months and 68 % at 6 months. In the pooled analysis of all dose cohorts, median PFS was 12.2 months, the 12‑month PFS rate was 51 %, and the overall response rate was 35 %. No patients discontinued treatment for anemia, and only 3 % stopped due to hypoxia.
These results represent the most favorable data yet for a HIF‑2α inhibitor in late‑line metastatic clear‑cell renal cell carcinoma and outperform the only marketed HIF‑2α inhibitor, belzutifan, as highlighted by chief medical officer Richard Markus. The data reinforce Arcus’s strategy to position casdatifan as its number‑one priority asset.
"Patients in the 100mg tablet cohort reached 15.1 months of PFS, and 45% had a confirmed response when treated with the same dose and formulation being used in the ongoing Phase 3 trial," said Richard Markus, M.D., Ph.D., chief medical officer at Arcus Biosciences. "HIF‑2a inhibition has emerged as a novel treatment that is changing the treatment paradigm for patients with ccRCC, and the results from ARC‑20 are very encouraging. I look forward to working with Arcus to bring this medicine to ccRCC patients as soon as possible," added Toni K. Choueiri, M.D., director of the Lank Center for Genitourinary Oncology at Dana‑Farber and lead investigator of ARC‑20.
The updated analysis will be presented at the American Society of Clinical Oncology Genitourinary Cancer Symposium on February 28, 2026, providing a platform for peer review and potential regulatory discussion. The data support the company’s goal of establishing casdatifan as the standard‑of‑care for clear‑cell renal cell carcinoma.
Arcus maintains a strong balance sheet with approximately $1 billion in cash and investments and a current ratio of 3.65, giving it sufficient runway to fund operations through the second half of 2028. The focus on casdatifan aligns with the company’s broader strategy to bring a next‑generation HIF‑2α inhibitor to patients as quickly as possible.
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